Responsible Conduct of Research

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Responsible Conduct of Research

• A Tri-institutional Program for
• Research Trainees
• 2003-2004

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Co-Sponsored by

• Memorial Sloan-Kettering Cancer Center
• The Rockefeller University
• Weill Medical College of
  Cornell University

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Course Staff

• Course Director
• Jeffrey M. Cohen, PhD, Associate Dean,
• Responsible Conduct of Research (RCR)
• Office of Research and Sponsored Programs
  (RASP)
• Weill Medical College of Cornell
  University jmc2011_at_med.cornell.edu 1 212
  821-0612
• Course Coordinator
• Debra Schaller-Demers, BA
• Education Coordinator, Research Integrity
• RCR, RASP, Weill Medical College of Cornell
  University
• des2010_at_med.cornell.edu 1 212 821-0675

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Planning Committee (in alphabetical order)

• Jeffrey M. Cohen, PhD, Associate Dean, RCR
• Weill Medical College jmc2011_at_med.cornell.edu
• Joseph Fins, MD, FACP, Chief Division of
  Medical Ethics
• Weill Medical College jjfins_at_med.cornell.edu
• Francoise Freyre, MA, Assistant Dean
• Weill Graduate School ffreyre_at_med.cornell.edu
• Emil Gotschlich,M.D., Vice President of
  Medical Sciences
• The Rockefeller University ecg_at_rockefeller.edu
• Prasad Jallepalli, MD, PhD, Assistant
  Professor
• Memorial Sloan-Kettering jallepap_at_mskcc.org
• Marguerite Lederberg, MD, Attending
  Psychiatrist
• Memorial Sloan-Kettering lederbem_at_mskcc.org

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Planning Committee continued

• Marguerite Mangin, Ph.D. Academic Programs
  Director
• The Rockefeller University manginm_at_rockefeller.edu
  
• Joel Pardee, PhD, Associate Dean
• Weill Graduate School jpardee_at_med.cornell.edu
• Debra Schaller-Demers, BA, Education Coord.,
  Research Integrity
• Weill Medical College des2010_at_med.cornell.edu
• Carolyn B. Schnall, MA, Conflicts Manager
• Weill Medical College cschnall_at_med.cornell.edu
• Gregory Siskind, MD, Consultant
• Weill Medical College gwsiskind_at_nyc.rr.com
• Linda Stevenson, Director, Research and
  Training Administration
• Memorial Sloan-Kettering stevensl_at_mskcc.org
• Sidney Strickland, PhD, Vice President,
  Educational Affairs

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Course Consultants

• Michael W. Kalichman, Ph.D.
• Adjunct Professor of Pathology
• Director, Research Ethics Program
• University of California, San Diego
• La Jolla, California 92093
• 1 858 822-2027 Fax [phone]
• kalichman_at_ucsd.edu
• Francis L. Macrina, Ph.D.
• Professor and Director
• The Philips Institute of Oral and Craniofacial
  Molecular Biology
• Virginia Commonwealth University, Richmond,
  Virginia
• 1 804 828-0149 Fax [phone]
• macrina_at_vcu.edu
• Author of
• Scientific Integrity - An Introductory Text with
  Cases 2nd Edition.
• ASM Press. Washington D.C. 2000

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Compliance - Federal Regulations

• NIH Training Grant Requirement (November 1992)
• Every predoctoral and postdoctoral NRSA
  trainee supported by a T32 or T34 institutional
  research grant must receive instruction in the
  responsible conduct of research.
• NIH Human Subjects Training (June 2000)
• Beginning Oct.1, 2000, the NIH will require
  education on the protection of human research
  participants for all investigators submitting NIH
  applications for grants or proposals for
  contracts or receiving new or non-competing
  awards for research involving human subjects.

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Introduction

• Each year since the early 1990s,
• Weill Medical College of Cornell University has
  collaborated with
• Memorial Sloan-Kettering Cancer Center and The
  Rockefeller University
• to sponsor a mandated ethics course for
  research trainees.

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Who MUST participate

• All 1st year graduate students
• All 1st year MD-PhD candidates
• Anyone appointed to NIH funded National Research
  Service Award Institutional Training Programs
  (NRSA T32, T34)

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Why Change the Course?

• Poor student evaluations
• Lack of content to analyze case studies
• Not meeting needs of diverse trainees
• Seen as nuisance obligation without relevance
• Not a meaningful educational experience

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Course Goals Objectives

• Awareness heighten awareness of trainees to
  ethical considerations relevant to the conduct of
  research
• Knowledge inform trainees of federal, state, and
  institutional policies, regulations, and
  procedures
• Skills provide trainees with critical analysis
  and problem solving skills for ethical
  decision-making

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Course TopicsEach topic will have a
corresponding case study assignment

• Research Misconduct (inc. whistle blowing)
• Data Management
• Use of Animal Subjects
• Use of Human Subjects

• Conflicts of Interest Commitment
• Authorship
• Peer Review Publication
• Collaboration Mentoring

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Course Components Criteria

• Online Course Work
• Four 4-week modules, each covering two topics.
• Online mini-test for each module.
• Passing mini-tests required to complete course
  and receive certificate
• Anyone not completing the course, must take the
  course in its entirety the following year
• Assignments
• Analysis of two case studies per module (one on
  each topic)
• Students will work in small groups
• Assigned at Orientation Session
• Group submits consensus paper on each case study
• Listservs will be formed to facilitate and
  encourage online discussion between group
  members.

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Module Face-to-Face Sessions

• Four sessions one every four weeks
• Students will meet in small groups for the first
  hour to prepare a consensus paper on the two
  assigned case studies for that month.
• For the second hour, the groups will reconvene in
  Uris Auditorium. One group will be selected at
  random to present their position. Other groups
  will be given a chance to comment and/or report
  out on their findings.

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Final Session - POV Plenary

• Two weeks after the completion of the four
  modules
• Students will meet in groups to discuss two
  additional case studies
• Groups will be assigned a particular Point of
  View (Sponsor, Dean, Investigator, Subject, etc)
  and analyze case studies from that perspective
• In the plenary session, one trainee from each
  group (each group having been assigned a
  different POV) will be selected at random to
  participate in a debate session discussing each
  of these final case studies.

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Course Schedule

• 1 small groups will be assigned at this meeting
• Tuesday, November 4 400-600 PM
• Check-in begins at 330 PM
• Orientation Session - from 400-530 PM
• Uris Auditorium
• Small Group Session - from 530-600 PM
• Weill Education Center
• Online Course begins
• Tuesday, November 11, 2003

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Course Schedule

• Four (4-week)Module Sessions - 400-600 PM
• 2 Tuesday, December 9 Cases 1 and 2
• 3 Tuesday, January 6 Cases 3 and 4
• 4 Tuesday, February 3 Cases 5 and 6
• 5 Tuesday, March 2 Cases 7 and 8
• Report to Small Group Rooms from 4-5 PM
• Weill Education Center
• Reconvene for Plenary Sessions from 5-6 PM
• Uris Auditorium

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Course Schedule

• 6 Final Session - 400-600 PM
• Tuesday, March 16th
• Report to Small Group Rooms from 4-5 PM
• Weill Education Center
• Reconvene for Plenary Session from 5-6 PM
• Special POV Case Study Analysis
• Uris Auditorium

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Faculty Participation

• Representatives from each Institutions
  Administrative Leadership to give opening remarks
  at first Orientation Session
• Faculty advisors (4-6) to float among small
  groups during the five small group working
  sessions.
• Plenary Facilitators (4-8) for Case Study
  Analysis discussions
• POV Panel Moderators (1-2) for final session Case
  Study Analysis

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Ongoing Training

• Integrated into all research training
• Follow-up sessions in departments
• Mentoring and continuous reinforcement

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Responsible Conduct of Research
Doing It Right Together!